Lichen Planus
Conditions
Keywords
Oral lichen planus, Dexamethasone solution
Brief summary
The objective of this single center, 4-week, open label randomized, phase II study is to evaluate and characterize the tolerability and clinical effectiveness of dexamethasone 0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen planus.
Detailed description
Potentially eligible subjects will be screened by one of the investigators by asking patients to rate their worst oral pain or pain score (0-10) over the previous week (see Appendix). Those answering with at least a score of 7 (1/10) and that meet all other eligibility requirements (see Section 3) will be eligible for enrollment. All patients will sign informed consent for study participation. Each study visit is anticipated to take approximately 45 minutes. Treatment will be administered on an outpatient basis. Study medication will be prescribed by authorized study staff physicians at no expense for the patient. Subjects will be evaluated clinically at baseline before starting treatment and at the end of the four-week period, for a total of two visits. Comprehensive subjective and objective data will be collected and intraoral photographs will be obtained. Oral mucosal disease will be evaluated using both patient reported (questions/visual analog scales) and clinician assessed measures. Subjects will be prescribed compound dexamethasone 0.5mg/5ml solution in Mucolox™ (ARM A) or dexamethasone 0.5mg/5ml solution only (ARM B). All subjects will also receive a prescription for fluconazole 200 mg tablets once-a-week as prophylactic antifungal therapy. Any subjects that are already taking an antifungal oral medication at the time of the study enrollment will continue their prescribed medication and will not need to take the additional weekly fluconazole dose. Subjects will return for evaluation after four weeks at which time the study end-points will be assessed. If there is worsening of oral lichen planus that requires initiation of new immunomodulatory medications (systemic or topical), patients will remain on treatment, but will be regarded as unevaluable for the primary endpoint.
Interventions
DRUGDexamethasone
Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older. * Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the last week).
Exclusion criteria
* Patients already on topical or systemic steroids. * Inability to comply with study instructions. * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements. * VAS sensitivity score \< 7.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Sensitivity | 4 weeks after the start of the trial | Subjects scored their worse sensitivity while eating over the past week. This score is substracted from their initial reported sensitivity at baseline. Reduction in oral symptoms of the worst sensitivity experienced in the past week on an 11 point scale (visual analogue scale 0-10). O signifies no sensitivity; 10 maximum sensitivity substracted from the same score collected at baseline before the treatment was initiated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Solution Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks
Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate | 12 |
| Dexamethasone Solution in Mucolox™ Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks
Dexamethasone: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Dexamethasone Solution | Dexamethasone Solution in Mucolox™ | Total |
|---|---|---|---|
| Age, Continuous | 80.2 years | 58.8 years | 69.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 12 Participants | 24 Participants |
| Sensitivity at baseline on a 0-10 scale | 8 units on a scale | 8 units on a scale | 8 units on a scale |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 1 / 12 | 0 / 12 |
Outcome results
Primary
Change in Oral Sensitivity
Subjects scored their worse sensitivity while eating over the past week. This score is substracted from their initial reported sensitivity at baseline. Reduction in oral symptoms of the worst sensitivity experienced in the past week on an 11 point scale (visual analogue scale 0-10). O signifies no sensitivity; 10 maximum sensitivity substracted from the same score collected at baseline before the treatment was initiated.
Time frame: 4 weeks after the start of the trial
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Rinses | Change in Oral Sensitivity | -4.5 score on a scale | Standard Error 2.5 |
| Dexamethasone in Mucolox Rinses | Change in Oral Sensitivity | -6.0 score on a scale | Standard Error 1.5 |